ARTG 465145

Analyser software IVDs

ARTG ID: 465145 · Abacus dx Pty Ltd · CerTest Biotec SL · Class IIa · Started October 21, 2024

Good Name: Abacus dx Pty Ltd - Analyser software IVDs

Device classification

Risk Class: Class IIa
Product Type: IVD
ARTG Category: IVD

Registration information

ARTG ID: 465145
Start Date: October 21, 2024
Effective Date: October 21, 2024

Sponsor

Name: Abacus dx Pty Ltd

Manufacturer

Name: CerTest Biotec SL
Country: Spain
Address: Poligono Industrial Rio Gallego II Calle J No 1, San Mateo de Gallego, Zaragoza, 50840

Intended purpose

VIASURE V-Smart is a stand-alone software that supports the automated interpretation, analysis and visualization of quantitative and qualitative Real-Time PCR Cycler raw data derived from VIASURE Real Time PCR Kits, into tests results.

About this record

Access comprehensive regulatory information for Analyser software IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 465145 and sponsored by Abacus dx Pty Ltd, manufactured by CerTest Biotec SL in Spain. The device registration started on October 21, 2024.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.